The artus HCV RG RT-PCR Kit and the artus HCV QS-RGQ Kit are ready-to-use molecular detection kits for real-time RT-PCR on Rotor-Gene instruments. The kits provide all necessary reagents optimized for reliable HCV RNA detection and quantitation for in vitro diagnostic use. The artus HCV RG RT-PCR Kit uses manual sample preparation and assay setup techniques. The artus HCV QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.

To ensure highest sensitivity, artus HCV Kits have been optimized to detect low numbers of HCV RNA. The analytical sensitivity of the artus HCV QS-RGQ Kits is 21 IU/ml in consideration of the purification and assay setup using the QIAsymphony RGQ system (see table "Hit rate analysis for HCV LOD study (data was used for probit analysis and verification study)" below). (1 IU/ml corresponds to 1.21 copies/ml for detection of HCV RNA on the QIAsymphony RGQ system. The conversion factor is an approximation based on an average factor across the assay's dynamic range.)

Hit rate analysis for HCV LOD study (data was used for probit analysis and verification study)

HCV titer (IU/ml)

Total replicate number

Total number positive

Percentage of positives

Probit analysis

150

12

12

100

100

12

12

100

50

12

12

100

30

32

32

100

20

60

59

98

15

60

51

85

5

60

40

67

0.316

57

3

5

Verification

20

60

57

95.00

For highest specificity, validation of the artus HCV Kits was carried out using various HCV isolates, including all genotypes 1–6 and related pathogens.

Performance characteristics of artus HCV Kits

Kit

artus HCV RG RT-PCR Kit

artus HCV QS-RGQ Kit

Validated sample type

EDTA plasma

EDTA plasma

Analytical sensitivity

34 IU/ml

21 IU/ml

Linear range

65 to 1 x 106 IU/ml

35.0 to 1.77 x 107 IU/ml

Specificity

HCV genotypes 1–6

HCV genotypes 1–6

Principle

The artus HCV RG RT-PCR Kit and the artus HCV QS-RGQ Kit are based on the amplification and simultaneous detection of a specific region of the HCV genome using real-time RT-PCR. The kits provide high levels of specificity, sensitivity, and reproducibility over a broad linear range.
Each artus HCV Kit provides 4 HCV quantitation standards (see figure "Reliable quantitation of HCV load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contains a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical HCV PCR is not reduced.

Specifications of artus HCV Kits

Kit

artus HCV RG RT-PCR Kit and artus HCV QS-RGQ Kit

Validated sample type

EDTA plasma

Amplicon

240 nt region of the 5' UTR

Procedure

artus HCV RT-PCR Kits provide all necessary reagents optimized for reliable HCV RNA detection and quantitation. Simply add template RNA to the ready-to-use PCR master mix, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Complete automated system from sample to HCV detection

The QIAsymphony RGQ workflow solution for HCV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus HCV QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a complete CE-IVD-compliant workflow (see figure "Integrated QIAsymphony RGQ system for HCV detection").

Recommendations for manual viral RNA purification

The artus HCV RG RT-PCR Kit is validated for use with viral RNA purified from human plasma using the CE-marked QIAamp DSP Virus Kit.